INSTALLING AN ISO -9001 QM SYSTEM:Implementation, Audit and Registration

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Total Quality Management MGT510

Lesson # 29

INSTALLING AN ISO -9001 QM SYSTEM

ISO 9001's requirements for quality management systems are also generic in nature, and are applicable

to organizations in any industry or economic sector. Whether the organization manufactures a product

or provides a service, whether it is a company or a governmental agency, whether it is large or small,

ISO 9000 can apply, and be used to advantage. To be registered the organization must go through a

process that includes the following steps:

Develop (or upgrade) a quality manual that describes how the company will assure the quality

of its products or services.

Document procedures (or upgrade existing documentation) that describe how the various

processes for design, production, continual improvement, and so forth, will be operated. This

must include procedures for management review/audits and the like.

10.

The organization must provide evidence of top management's commitment to the QMS and its

continual improvement.

11.

The organization's top management must ensure that customer requirements are determined and

met.

12.

The organization must hire an accredited registrar company to examine its systems, processes,

procedures, quality manual, and related items. If everything is in order, registration will be

granted. Otherwise, the registrar will inform the company of which areas require work (but will

not inform the company specifically what must be done), and a second visit will be scheduled.

13.

Once registration is accomplished, the company will conduct its own internal audits to ensure

that the systems, processes, and procedures are working as intended.

14.

Also once registered, the outside registrar will make periodic audits for the same purpose. These

audits must be passed to retain registration.

An important point to understand about ISO 9000 is that the organization has to respond to all ISO 9000

requirements and tell the registrar specifically what it is going to do and how. ISO does not tell or advise

the organization. Assuming the registrar agrees with the organization's plan, registration is awarded. To

retain that registration, the organization must do what it said it would do.

Implementation, Audit and Registration

The registration process includes document review by the registrar of the quality system documents or

quality manual; pre-assessment, which identifies potential noncompliance in the quality system or in the

documentation; assessment by a team of two or three auditors of the quality system and its

documentation; and surveillance, or periodic re-audits to verify conformity with the practices and

systems registered. During the assessment, auditors might ask such question as (using management

responsibility as an example):

Does a documented policy on quality exist? Have job descriptions for people who manage or perform

work affecting quality been documented? Are descriptions of functions that affect quality been

documented? Are descriptions of functions that affect quality available? Has management designated a

person or group with the authority to prevent nonconformities in products, identify and record quality

problems, and recommend solutions? What means are used to verify the solutions?

Re-certification is required every three years. Individual sites not entire companies must achieve

registration individually. All costs are borne by the applicant, so the process can be quite expensive.

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